A Phase II Biomarker Trial of Gelatin Encapsulated Extract of American Ginseng Root (LEAG) in Breast Cancer: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Phase II Biomarker Trial of Gelatin Encapsulated Extract of American Ginseng Root (LEAG) in Breast Cancer (NCT00631852), a na phase 2 study. The primary outcome is Adiponectin.

2. Clinical Question

3. Trial Design

The registry identifies this as a Phase II biomarker trial of gelatin-encapsulated American ginseng root extract in breast cancer. It was sponsored by Southern Illinois University and is recorded as completed. The study start is listed as 2008-02, and primary completion as 2019-06-30. Enrollment is recorded as 16.

The design is single-group, with masking listed as none and allocation as NA. Participants received American ginseng root extract before surgery; the arm description specifies four 250mg tablets daily 5-14 days prior to surgery. Since no comparison arm is described, the design can characterize measurements in the treated group but cannot estimate a randomized treatment-versus-control contrast.

The study summary describes examination of changes in breast cancer tumors and surrounding normal breast epithelial cells, with tumor biomarkers and inflammatory mediators examined in tissue following treatment. The named primary endpoint is different in form: it is a serum marker, adiponectin, measured as change from baseline to treatment completion. The registry describes its timeframe as a mean of 11.8 days.

The record lists 19 outcome measures, but no analyses. It notes that serum markers were analyzed later because of funding issues and the principal investigator’s transfer to a new institution. Only 11 subjects’ specimens were able to be transferred to the new institution. This information gives context for the serum measurements, but the record does not specify the analysis population for the primary endpoint or report its result.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

Analysis population for the primary outcome, as defined in the registry: Serum markers were analyzed at a later date due to funding issues and PI transfer to new Institution. PI obtained funding through new Institution and only 11 subjects' specimens were able to be transferred to new Institution.

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

Population: Platelet assay limited to 5 subjects per protocol. Serum markers limited to 11 subjects due to transfer of specimens to PI at new Institution. Not all subjects provided permission for transfer.

6. Primary Endpoint

The registry lists the primary outcome as Adiponectin, measured over mean of 11.8 days.

The primary endpoint is change in serum adiponectin from baseline to completion of treatment with LEAG. Adiponectin is reported in pg/ml, and the endpoint is specified as a mean with standard deviation as its dispersion measure. The timeframe is described as a mean of 11.8 days.

A change endpoint compares measurements made at different times for the same study group. In general, it can describe whether the measured marker was higher or lower at treatment completion than at baseline, and by how much. A mean summarizes the group’s average change, while a standard deviation describes variability among measured values. These summaries do not, on their own, establish that the intervention caused a change; without a comparison group, other explanations for change over time cannot be separated from an intervention effect.

The study summary emphasizes tumor tissue, surrounding normal breast epithelial cells, tumor biomarkers, and inflammatory mediators. The registry record does not explain why adiponectin was selected as the primary endpoint or describe its clinical interpretation. It also does not report baseline or completion values, the mean change, a standard deviation, a confidence interval, or a test result. As a result, the endpoint’s direction, magnitude, and precision cannot be evaluated from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry lists adiponectin as a continuous outcome, summarized as a mean with standard deviation. A continuous measure can take values across a scale rather than being limited to event categories. The mean describes the average value or average change in a group. The standard deviation describes how spread out individual values are around that average; it is not itself a measure of uncertainty in the estimated mean.

What does a change endpoint represent?

The primary endpoint is described as change from baseline to completion of treatment. In general, a change score is formed by comparing a participant’s later measurement with that participant’s earlier measurement, then summarizing those changes across the analysis group. This approach focuses on within-participant movement over time. The registry record does not state the exact calculation convention, the number of paired observations, or whether the analysis used a model beyond a mean change.

Repeated measurements on the same participant are generally related rather than independent. In general, an analysis of change should account for that relationship, either by working directly with individual changes or through a model that represents the repeated measurements. The record does not report which approach was used. Without individual-level data or a stated analysis, the reported endpoint definition alone is not enough to reconstruct an inferential analysis.

What do the mean and standard deviation tell readers?

In general, the mean locates the average response, while the standard deviation describes variation across observed responses. A confidence interval, if reported, would convey uncertainty around an estimated quantity under the assumptions of the analysis. It is not listed for this primary endpoint. The registry record also does not report the actual mean or standard deviation, so neither the observed group change nor its variability can be interpreted.

Some analyses of count data use methods that allow for over-dispersion. General explanation: over-dispersion occurs when count variability exceeds what a simpler model assumes; ignoring it can make uncertainty estimates too small. This issue is not a stated feature of the continuous adiponectin endpoint, and the registry does not report whether any count outcomes were analyzed or what methods were applied to them.

What can a p-value establish?

In general, a p-value describes how compatible data are with a specified statistical model and null hypothesis, assuming the model and hypothesis are appropriate. It is not a measure of the probability that a treatment works, nor does it convey the size or clinical importance of an effect. The registry record lists no p-value or test for the primary endpoint. It is therefore not possible to judge statistical evidence for a change from the posted result record.

How should planning illustrations be read?

Planning illustrations based on an observed effect are not observed power and are not a description of the trial’s original design. In general, such illustrations show how participant requirements might vary under specified assumptions about an effect to detect, allocation, significance level, and statistical approximation. The assumptions recorded for these illustrations are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is stated as a fraction of the observed effect. The record explicitly characterizes these as planning illustrations, not the trial’s own design. That two-arm planning assumption does not match the actual single-group design. No numerical planning result is reported in the registry information available for this explanation.

For time-to-event outcomes, a common planning approach relates the number of events to the planned comparison. The registry’s planning note distinguishes total events for time-to-event illustrations from participants per arm for other illustrations. The primary endpoint in this trial is continuous, not time-to-event. The registry record does not provide a time-to-event primary endpoint or report any corresponding analysis.

More broadly, a planned sample size, an observed enrollment, an analyzed population, and a number of outcome measurements are different quantities. The record reports enrollment of 16 and 19 outcome measures, but no analyses. Its note about transferred specimens does not by itself specify the primary endpoint analysis population. These distinctions matter because the available data and the analysis method determine the precision and interpretation of an estimate.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("American Ginseng Root")
n   <- c(11)
m   <- c(1308)
sp  <- c(11.985)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  American Ginseng Root  11  1308.000  11.985  1299.948  1316.052

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 19 outcome measures and no analyses. It does not identify a statistical analysis plan, specify which outcomes were tested, describe a hierarchy among endpoints, or report an adjustment for multiple comparisons. When several outcomes are examined, general statistical interpretation recognizes that the chance of at least one apparently unusual result can increase if many tests are considered without accounting for multiplicity. The registry record does not provide enough information to determine whether or how this issue was addressed.

The primary endpoint is change in adiponectin, but its numerical result and analysis are not reported. The record also does not state whether the primary endpoint was analyzed according to a prespecified population, whether baseline measurements were available for all participants, or how missing measurements were handled.

The registry notes that serum markers were analyzed later because of funding issues and the principal investigator’s transfer to a new institution. It says only 11 subjects’ specimens were able to be transferred to the new institution. This raises a relevant question about the availability of serum specimens, but the record does not say whether all transferred specimens were usable, which participants had measurements at both time points, or whether missingness was handled by exclusion, imputation, or another method. Those details are not reported in the registry record.

The record also does not describe an intention-to-treat population, a per-protocol population, or another analysis population. In a single-group biomarker study, clarity about which participants contributed paired measurements is important for understanding the mean change and its uncertainty. The available reporting does not permit that assessment.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: hemorrhage/ bleeding (6.2%).

For the American Ginseng Root group, the registry reports one serious adverse event among 16 participants at risk. It reports 15 other adverse events among 16 at risk, and zero deaths. Hemorrhage/ bleeding is listed among the top serious terms at 6.2%.

These figures describe recorded events and denominators in the study group. The serious and other adverse event counts are separate registry categories; they should not be added or treated as a count of unique people, since the record does not say whether any participant had events in more than one category or more than one event. The term-level percentage is reported as 6.2%; the record does not give additional detail about its calculation or event-level context.

Adverse events observed during a study are not automatically caused by the intervention. This trial has no like-for-like control group, so the safety figures do not provide a comparative estimate of risk. The registry record does not state the investigators’ causality assessments or give further details about event timing, severity beyond the serious-event category, or outcomes. The figures should therefore be read as descriptive safety reporting, not as proof for or against a causal relationship.

13. What the Result Does, and Does Not, Mean

This registry record documents a Phase II, single-group biomarker study in breast cancer. It identifies American ginseng root extract as the intervention and describes its use before surgery. The stated primary endpoint is change in serum adiponectin from baseline to treatment completion, expressed in pg/ml, with a mean of 11.8 days given for the timeframe.

Those details define the intended measurement, but they are not a numerical result. The registry does not report the mean adiponectin change, the baseline and completion values, the standard deviation, a confidence interval, or a statistical test. The available record therefore does not show whether adiponectin increased or decreased, how large any change was, or how precisely it was estimated.

Even if a within-group change were reported, the design would limit causal interpretation. General statistical explanation: without a concurrent control group, a before-and-after comparison cannot distinguish an intervention-associated change from other influences that may occur over time. The record also does not provide the analysis method or clarify exactly which serum measurements contributed to the endpoint.

The study summary describes examination of tumor biomarkers, inflammatory mediators, and breast tissue. The named primary endpoint is a serum marker, and the registry record does not provide a rationale linking its measured change to a clinical outcome. The record does not establish an effect on cancer outcomes or describe a comparison with another treatment.

The safety counts are descriptive reports from the single group. They do not establish that the intervention caused or prevented adverse events. In short, the registry supports a description of the study’s purpose and design, but its missing primary result and analysis details prevent conclusions about the size, precision, or causal meaning of an adiponectin change.

14. Why This Trial Matters Statistically

This trial illustrates why a clear distinction between a study question and a reported result matters. The record names a specific biomarker endpoint and describes a measurement before and after a short pre-surgical intervention period. Yet it does not report the endpoint estimate or its uncertainty. A defined endpoint alone cannot tell readers what was observed.

The design also makes the statistical question narrower than a treatment comparison. A single-group study can describe measurements within the enrolled group, but it has no concurrent control group against which to compare those measurements. This is an important design feature when interpreting any apparent change over time. It limits causal attribution even when a complete result is reported.

The registry’s note about serum specimens adds another practical consideration. Serum markers were analyzed later because of funding issues and the principal investigator’s transfer, and only 11 subjects’ specimens could be transferred. Such information makes it especially important to report the analysis population, availability of paired measurements, and methods for handling missing data. Those details are not reported for the primary endpoint.

The record lists 19 outcome measures but no analyses. This underscores the value of transparent reporting about which endpoints were analyzed, how they were analyzed, and whether multiplicity was considered. Without those details, readers cannot assess the statistical evidence or compare the primary endpoint with other measured outcomes.

For biostatistical interpretation, the case highlights that enrollment, specimen availability, analyzed observations, and estimated effects are not interchangeable. Each answers a different question. The registry describes some of these elements, but not enough to reconstruct or evaluate the primary statistical result.

15. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The registry record does not report the numerical result for the primary endpoint. It gives no baseline or completion adiponectin summary, mean change, standard deviation, confidence interval, or p-value. Consequently, neither effect size nor precision can be assessed.

The single-group design has no like-for-like control comparison. A within-group change, if available, would not by itself establish that the intervention caused the change. The record also lists masking as none, and does not report methods that might address measurement or analysis bias.

The record notes delayed analysis of serum markers because of funding issues and the principal investigator’s transfer to a new institution. Only 11 subjects’ specimens were able to be transferred. It does not identify the primary endpoint analysis population, state how many paired measurements were available, or explain the handling of missing specimens.

Although 19 outcome measures are listed, no analyses are listed. The statistical analysis plan, endpoint hierarchy, and any approach to multiplicity are not reported in the registry record. The record does not state a sample-size justification or explain the trial’s original planning assumptions. Planning illustrations based on an observed effect are not a substitute for the trial’s design rationale or an analysis of observed data.

The safety information is brief. The record gives adverse-event counts and a serious-event term, but not further event-level context or causality assessments. These limitations constrain interpretation of both the biomarker question and the descriptive safety information.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: A Phase II Biomarker Trial of Gelatin Encapsulated Extract of American Ginseng Root (LEAG) in Breast Cancer — NCT00631852.
• Registry record last updated 2026-05-12; status last verified 2021-11.
• Results first posted 2021-11-11.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

19. Record Summary

NCT00631852 is a completed Phase II, single-group biomarker trial sponsored by Southern Illinois University. The study concerns gelatin-encapsulated American ginseng root extract in breast cancer. The intervention description specifies four 250mg tablets daily 5-14 days prior to surgery. The registry lists enrollment of 16, a start of 2008-02, and primary completion on 2019-06-30.

The primary endpoint is change in serum adiponectin from baseline to treatment completion, measured in pg/ml and summarized as a mean with standard deviation. Its timeframe is given as a mean of 11.8 days. The record lists 19 outcome measures but no analyses and does not report a numerical result for the primary endpoint. It notes that only 11 subjects’ specimens were able to be transferred for later serum-marker analysis.

Safety reporting includes one serious adverse event among 16 at risk, 15 other adverse events among 16 at risk, and no deaths. Hemorrhage/ bleeding is listed among the top serious terms at 6.2%. The single-group design and missing primary analysis limit interpretation of efficacy, precision, and causal effects.